Outcomes of Perforation After Colorectal Endoscopic Submucosal Dissection

Active, not recruiting

• Conditions: Colorectal Neoplasms; Perforation of Rectum; Perforation Colon
• Interventions: Procedure: Endoscopic submucosal dissection

• Registration Number: NCT05728710
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

Endoscopic resection of superficial colorectal neoplasms decrease risk of colorectal cancer. En bloc resection is necessary for large superficial lesions with risk of superficial submucosal cancer and is advised if feasible for all lesions. Endoscopic submucosal dissection (ESD) allows en bloc resection of large superficial colorectal neoplasms, increasing curative resection rate and decreasing local recurrence risk. However, the risk of perprocedural or delayed perforation is higher compared to wild field piece meal endoscopic mucosal resection. Endoscoping clipping and closing methods mostly allow conservative treatment, but some case still necessitate surgery. The aim of our study is to describe and ananalyse outcomes after perprocedural or delayed perforation in all patients undergoing ESD and analyse the need for surgical intervention.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-01
• Status Verified: 2023-02
• Study First Submitted: 2023-02-06
• Study First Submitted QC: 2023-02-06
• Last Update Submitted: 2023-02-06
• Study First Posted: 2023-02-15
• Last Update Posted: 2023-02-15
• Primary Completion: 2023-03-31
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• patients from the FECCO (NCT04592003) cohort experiencing perprocedural or delayed perforation
• age over 18 years old

Exclusion Criteria

• patients refusing exploitations of health datas
• patient treated with endoscopic mucosal resection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Perforation	Endoscopic submucosal dissection	all patients with immediate or delayed perforation identified from the FECCO (NCT04592003)

Primary Outcome Measures

Name	Time	Method
Surgery	30 days	Rate of surgery following perforation after ESD

Secondary Outcome Measures

Name	Time	Method
30-days mortality rate	30 days
Hospital stay	60 days	length of hospital stay (days)
Hospital readmission	30 days
Curative resection rate	60 days
Endoscopically closed perforation rate	30 days
Risk factors for endoscopic closure failure	30 days

Trial Locations

Locations (13)

Clinique CHC; 🇧🇪 Liège, Belgium

CHU Bordeaux; 🇫🇷 Bordeaux, France

Nancy Hospital Center; 🇫🇷 Nancy, France

CHU Dijon; 🇫🇷 Dijon, France

Hopital Edouard Herriot; 🇫🇷 Lyon, France

Hopital Privé Jean Mermoz; 🇫🇷 Lyon, France

Clinique Jules Verne; 🇫🇷 Nantes, France

CHU Dupuytren; 🇫🇷 Limoges, France

Hopital Europeen Georges Pompidou; 🇫🇷 Paris, France

Clinique Anjou; 🇫🇷 Angers, France

Hôpital Cochin; 🇫🇷 Paris, France

CHU de Rennes; 🇫🇷 Rennes, France

Hôpital Saint Joseph; 🇫🇷 Paris, France